The FDA is expected to decide on Rivoceranib + camrelizumab for Unresectable or metastatic hepatocellular carcinoma (HCC), first-line by April 9, 2027, under an NDA and BLA resubmissions from Elevar Therapeutics / Hengrui Pharma.
What the FDA is deciding on Rivoceranib + camrelizumab for HCC
The FDA is reviewing Elevar Therapeutics / Hengrui Pharma's resubmitted application to approve Rivoceranib + camrelizumab for unresectable or metastatic hepatocellular carcinoma (HCC), first-line, sent back after the FDA turned down an earlier version.
Elevar resubmitted its application for rivoceranib, a daily pill that blocks the VEGF growth signal tumors use to build blood vessels, and Hengrui resubmitted its application for camrelizumab, an immunotherapy infusion, on October 9, 2026. The FDA reviews the 2 together as 1 treatment for liver cancer that cannot be removed by surgery.
It is the response to a complete response letter the FDA issued in July 2026. In the Phase 3 CARES-310 trial, people on the combination lived a median 23.8 months against 15.2 months on sorafenib, an older pill for liver cancer.
What an approval or a rejection of Rivoceranib + camrelizumab would mean
An approval starts a second race rather than ending the first one: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. Our guide to the 90 days after a rare disease approval explains the timeline and the moves families can make on day 1.
A complete response letter would mean the FDA declined to approve in the application's current form. The letter describes what the FDA wants addressed, and the company then decides whether to resubmit, run more studies or stop. Either way, this page updates with the outcome and what it means.
Frequently asked questions
When will the FDA decide on Rivoceranib + camrelizumab?
The FDA's target date (PDUFA date) for Rivoceranib + camrelizumab in Unresectable or metastatic hepatocellular carcinoma (HCC), first-line is April 9, 2027.
Who disclosed it: Elevar Therapeutics / Hengrui Pharma. The FDA does not publish these dates.
Can it move: the FDA can act early, and a major amendment to the application can push the date back 3 months.
What is Rivoceranib + camrelizumab being reviewed for?
Elevar Therapeutics / Hengrui Pharma submitted an NDA and BLA resubmissions for Rivoceranib + camrelizumab in Unresectable or metastatic hepatocellular carcinoma (HCC), first-line.
What to know: Elevar resubmitted its application for rivoceranib, a daily pill that blocks the VEGF growth signal tumors use to build blood vessels, and Hengrui resubmitted its application for camrelizumab, an immunotherapy infusion, on October 9, 2026. The FDA reviews the 2 together as 1 treatment for liver cancer that cannot be removed by surgery. It is the response to a complete response letter the FDA issued in July 2026. In the Phase 3 CARES-310 trial, people on the combination lived a median 23.8 months against 15.2 months on sorafenib, an older pill for liver cancer.
How much will Rivoceranib + camrelizumab cost?
Elevar Therapeutics / Hengrui Pharma has not announced a price. Drugmakers usually set it around approval.
Help paying: drugmaker programs and charity funds usually open at launch.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the Rivoceranib + camrelizumab decision?
This page updates with the outcome the day it is announced.
If approved: getting the drug still takes time. Specialty pharmacy setup, insurance review and patient assistance often take weeks. Our guide covers what families can do on day 1.
If not approved: a complete response letter means the FDA declined the application in its current form. Many are about manufacturing or how data were presented, and companies often resubmit.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from Elevar press release, November 4, 2026. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.